IDE used for fast tracking to markethttps://en.wikipedia.org/wiki/Investigational_Device_Exemption
An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical studyin order to collect safety and effectiveness data required to support aPremarket Approval (PMA) application or a Premarket Notification[510(k)] submission to Food and Drug Administration(FDA). Clinical studies are most often conducted to support a PMA. Onlya small percentage of 510(k)'s require clinical data to support theapplication. Investigational use also includes clinical evaluation ofcertain modifications or new intended uses of legally marketed devices.All clinical evaluations of investigational devices, unless exempt, musthave an approved IDE before the study is initiated.